EP3996526A1 - Composition for use in inducing satiety - Google Patents

Composition for use in inducing satiety

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Publication number
EP3996526A1
EP3996526A1 EP20737017.2A EP20737017A EP3996526A1 EP 3996526 A1 EP3996526 A1 EP 3996526A1 EP 20737017 A EP20737017 A EP 20737017A EP 3996526 A1 EP3996526 A1 EP 3996526A1
Authority
EP
European Patent Office
Prior art keywords
lipid
composition
person
globules
hmo
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20737017.2A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jeske Helena Johanna HAGEMAN
Arie Gijsbert Nieuwenhuizen
Jaap Keijer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
FrieslandCampina Nederland BV
Original Assignee
FrieslandCampina Nederland BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by FrieslandCampina Nederland BV filed Critical FrieslandCampina Nederland BV
Publication of EP3996526A1 publication Critical patent/EP3996526A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/152—Milk preparations; Milk powder or milk powder preparations containing additives
    • A23C9/1528—Fatty acids; Mono- or diglycerides; Petroleum jelly; Paraffine; Phospholipids; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/20—Dietetic milk products not covered by groups A23C9/12 - A23C9/18
    • A23C9/203—Dietetic milk products not covered by groups A23C9/12 - A23C9/18 containing bifidus-active substances, e.g. lactulose; containing oligosaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/38—Other non-alcoholic beverages
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the invention disclosed herein relates to the field of weight management. More in particular, the invention relates to a method for inducing satiety.
  • Nutritional compositions for infants aim to resemble human milk as much as possible, as human milk is generally seen as the ideal source of nutrition for infants up to at least 6 months of age. Although infant formula have become better and better over time, there are still important differences between human milk and infant formula.
  • Obesity is now prevalent even among our youngest children: during 2011—2012, 8.1 % of infants and toddlers had weight-for-recumbent-length that was greater than the 95th percentile in the USA (Ogden et al 2014 JAMA Vol 31 1 , Nr 8 pp 806-814). This is particularly alarming because once obesity develops in these early years, it is likely to persist into adulthood, laying the foundation for the continued presence of obesity and related comorbid conditions, such as diabetes and cardiovascular disease, across future generations. Rapid weight gain during the first months of life is an indicator of early childhood obesity (Haire- Joshu et al Annu Rev Public Health. 2016; 37: 253-271 ; doi: 10.1146/annurev-publhealth- 032315-021859).
  • satiety Diet-induced satiety may be protective against childhood obesity. Gastrointestinal signals are crucial for the regulation of food intake, satiety and satiation. As used herein,“satiation” refers to the end of desire to eat after a meal, and this can occur at any time after the onset of eating. It is governed by hormones and stretch receptors in the stomach. Satiation signals the brain the meal is over.“Satiety,” on the other hand, is a physical feeling of fullness that allows us to stop eating for a while. Ideally, satiety dwindles as nutrients diminish. When nutrients diminish, hunger returns.
  • Satiety feelings on a meal-to-meal basis are to a large extent determined by a coordinated series of neural and humoral signals that originate from the gut in response to mechanical and chemical properties of ingested food (Woods SC; Gastrointestinal satiety signals I. An overview of gastrointestinal signals that influence food intake. Am J Physiol Gastrointest Liver Physiol 286:G7-G13, 2004).
  • Fat consists of triacylglycerols (TAG) that contain fatty acids esterified at the sn-1 , sn-2 and sn-3 position of a glycerol molecule.
  • TAG triacylglycerols
  • Human and bovine milk fat contain a wide range of fatty acids, including short-chain fatty acids (SCFA), medium-chain fatty acids (MCFA), and long- chain fatty acids (LCFA), which can either be saturated or unsaturated. Vegetable fat can also contain some MCFA, but does not contain SCFA.
  • SCFA short-chain fatty acids
  • MCFA medium-chain fatty acids
  • LCFA long- chain fatty acids
  • Vegetable fat can also contain some MCFA, but does not contain SCFA.
  • human milk fat, bovine milk fat and vegetable oils such as palm oil are all rich in palmitic acid (C16:0), the distribution of palmitic acid over the glycerol backbone differs among these different lipid sources. In
  • said method comprising feeding said infant an infant formula or follow on formula comprising lipid, protein and digestible carbohydrates, and wherein the lipid comprises i) 30 to 90 wt.% vegetable lipid based on total lipid, and ii) 10 to 70 wt.% based on total lipid of mammalian milk lipid derived from the group consisting of butter, butter fat, butter oil, and anhydrous milk fat wherein the lipid is in the form of lipid globules, which had a mode diameter, based on volume, of about 5.6 pm, and the volume % of lipid globules with a diameter between 2 and 12 pm was above 45%.
  • WO2009131436 discloses a satiety enhancing drinking yoghurt having a prolonged shelf life comprising carboxymethyl cellulose.
  • the drinking yoghurt preferably comprises milk fat in an amount of less than about 1 wt%, more preferably in an amount of less than about 0.5 wt%, even more preferably in an amount of less than about 0.1 wt% with respect to the weight of the drinking yoghurt.
  • Maljaars et al disclose that the effect of lipid droplet size on satiety and peptide secretion is intestinal-site specific, by infusion of a fine or coarse fat emulsion into duodenum or ileum (P.W. Jeroen Maljaars et a! 2012 Clinical Nutrition 31 pp 535-542). It is desired that further compositions be provided that can be used in a method to reduce overweight, e.g. in a method to induce satiety.
  • compositions that can be used in such a method and that are readily acceptable, e.g. that can be combined with a normal diet.
  • the invention relates to a method for inducing satiety in a person, said method comprising administering to the person a composition comprising lipid, protein and digestible carbohydrates; wherein the lipid comprises i. 30 to 90 wt.% vegetable fat, and ii.
  • composition characterized in that the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%.
  • the invention also relates to a weight reduction or weight maintenance program comprising providing a person such a composition.
  • the invention further relates to a non-medical method for inducing satiety in a person comprising administering a person a composition as defined in any of the preceding claims; a composition comprising lipid, protein and digestible carbohydrates;
  • the lipid comprises i. 30 to 90 wt.% vegetable fat, and ii. 10 to 70 wt.% mammalian milk fat, wherein all wt.% are based on total lipid of the composition, characterized in that the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60% for use in inducing satiety in a person.
  • the invention also relates to the use of lipid, protein and digestible carbohydrates; wherein the lipid comprises i. 30 to 90 wt.% vegetable fat, and ii. 10 to 70 wt.% mammalian milk fat, wherein all wt.% are based on total lipid of the composition, characterized in that the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60% in the manufacture of a composition for inducing satiety in a person.
  • treatment in relation a given disease or disorder, includes, but is not limited to, inhibiting the disease or disorder, for example, arresting the development of the disease or disorder; relieving the disease or disorder, for example, causing regression of the disease or disorder; or relieving a condition caused by or resulting from the disease or disorder, for example, relieving, preventing or treating symptoms of the disease or disorder.
  • prevention in relation to a given disease or disorder means preventing the onset of disease development if none had occurred, preventing the disease or disorder from occurring in a subject that may be predisposed to the disorder or disease but has not yet been diagnosed as having the disorder or disease, and/or preventing further
  • any reference to a weight, weight ratio, and the like pertains to the dry matter, in particular the dry matter of the composition.
  • the term “comprising”, which is synonymous with “including” or “containing”, is open-ended, and does not exclude additional, unrecited element(s), ingredient(s) or method step(s), whereas the term “consisting of” is a closed term, which excludes any additional element, step, or ingredient which is not explicitly recited.
  • the term“essentially consisting of” is a partially open term, which does not exclude additional, unrecited element(s), step(s), or ingredient(s), as long as these additional element(s), step(s) or ingredient(s) do not materially affect the basic and novel properties of the invention.
  • the term“comprising” hence includes the term “consisting of’ (“consist(s) of”), as well as the term“essentially consisting of’ (“essentially consist(s) of”). Accordingly, the term“comprising” (or“comprise(s)”) is, in the present application, meant as more particularly encompassing the term“consisting of” (“consist(s) of’), and the term“essentially consisting of’ (“essentially consist(s) of”).
  • the term "subject” as used herein refers to a human, that is treatable by the method of the invention.
  • the term “subject” refers to both the male and female sex unless one sex is specifically indicated.
  • the human subject can be an infant (3 2 years old), a juvenile, an adolescent, an adult or an elderly subject.
  • The“mode diameter” as used herein relates to the diameter which is the most present based on volume of total lipid, i.e. the peak value in a graphic representation, having on the X-axis the diameter and on the Y-axis the volume(%).
  • the volume distribution of the particle diameter of the lipid globules is determined using“Laser Diffraction Particle Sizing”, for example using a Malvern Mastersizer apparatus.
  • the invention in a first aspect, relates to a method for inducing satiety in a person, said method comprising administering to the person a composition comprising lipid, protein and digestible carbohydrates; wherein the lipid comprises
  • the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90%.
  • administering a composition to a person comprises feeding a person such as a child, baby, or infant, it also includes the person eating or drinking the composition.
  • the preferred route of administration is oral administration.
  • the invention provides a method for inducing satiety, i.e. a method for inducing postprandial events that prolong the feeling of fullness and increase the time for feelings of hunger and prospective consumption to return to pre-prandial levels and thereby regulating meal frequency or meal size, as well as reducing eating or snacking in between meals. This may also be referred to as a method for providing an appetite suppressing effect.
  • A“prolongation in the feeling of fullness” and/or an“increase of time for feelings of hunger and prospective consumption to return” are defined by comparing satiety feelings in a group of subjects (e.g. 5, preferably at least 10 subjects, more preferably at least 20 subjects) fed a composition as defined in the invention, compared to a group of subjects (of the same age, BMI group and size), fed a placebo composition (similar and isoenergetic and equal in nutrients as defined in the invention that comprises only vegetable fat as lipid source with a mode diameter, based on volume, of between 0.4 pm and 0.5 pm, preferably with a mode diameter of 0.46 ⁇ 0.05 pm.
  • the present invention can also be referred to as a non-medical method for inducing satiety in a person.
  • the invention can also be worded as the use of lipid, protein and digestible carbohydrates; wherein the lipid comprises i. 30 to 90 wt.% vegetable fat, and
  • the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90%, in the manufacture of a composition for inducing satiety in a person.
  • the invention can also be worded as a composition comprising lipid, protein and digestible carbohydrates; wherein the lipid comprises
  • the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90% for use in inducing satiety in a person.
  • the mammalian milk fat as used in the invention refers to milk fat obtained from mammalian milk, preferably from ruminants e.g. milk of sheep, cattle, or goat. More preferably, the mammalian milk fat is milk fat obtained from cattle, even more preferably it is bovine milk fat, most preferably cow’s milk fat.
  • the milk fat source can in principle be any available bovine milk fat source, such as whole milk, cream, anhydrous milk fat (AMF) or milk fat fractions resulting from dry fractionation, critical CO2 extraction or other fractionation methods known in the art. It was, however, found particularly suitable to use whole milk and/or cream as the milk fat source, more preferably to use bovine whole milk and/or cream as the milk fat source.
  • the mammalian milk fat is selected from the group consisting of bovine butter, bovine butter fat, bovine butter oil.
  • the fat composition can be prepared by combining the bovine milk fat source(s) with the vegetable lipid source by ways known in the art. Typically, both sources are combined in liquid form, mixed and stored at temperatures at which the blend remains liquid to avoid crystallization and under nitrogen to avoid fat oxidation. Accordingly, the fat composition would typically be stored at 35-50 °C under nitrogen. Alternatively, both sources can be mixed (e.g. when using cream or whole milk), other ingredients may be added, homogenized and spray dried, using methods known in the art. When further processing the fat composition, e.g. into a nutritional composition, the fat composition would be supplied in liquid form as described above and subsequently be processed by combining it with other ingredients.
  • the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 1.0 pm is above 60%, preferably above 70%, more preferably above 80, most preferably 82%.
  • the lipid globules have a mode diameter, based on volume, of between 0.1 pm and 1.0 pm, preferably of between 0.1 pm and 0.8 pm, more preferably of between 0.1 pm and 0.6 pm, most preferably between 0.3 pm and 0.5 pm.
  • the volume % of lipid globules with a diameter below 1.0 pm is above 85% and the lipid globules have a mode diameter, based on volume, of between 0.3 pm and 0.5 pm.
  • the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter above 0.06 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90%. In yet another embodiment, the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter above 0.10 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 85%.
  • the human subject is at least 18 years of age, e.g. at least 25 years, at least 30 years, at least 35 years, at least 40 years, at least 45 years, at least 50 years, at least 55 years, at least 60 years or at least 65 years of age.
  • human subjects treated in accordance with the invention will typically be at most 100 years of age, e.g. at most 95 or at most 90 years of age.
  • composition as used in various aspects of the invention is then selected from one or more of the group consisting of a milk product, a cereal product, a granola product, a nutritional bar, a fortified water, a fruit juice, a fruit smoothie a dairy smoothie, a dairy beverage, an energy drink, a baked good, and a yoghurt.
  • compositions as used in the different aspects of the invention comprising protein, digestible carbohydrates (typically lactose) and lipid, wherein the lipid source comprises the fat composition as described above, may optionally comprise other
  • ingredients such as non-digestible oligosaccharides (for example, fructo-oligosaccharides and/or galacto-oligosaccharides) and human milk oligosaccharides (HMO), may be included as well.
  • a composition may also be referred to as nutritional composition, is particularly suitable for human subjects of 0 to 36 months of age, in particular infants (a person of 0-12 months of age according to the CODEX Alimentarius (CODEX STAN 72-1981), further referred to as the CODEX) and young children up to the age of 36 months.
  • Nutritional compositions for infants are commonly referred to as infant formula.
  • the composition as used in the various aspects of the invention should contain the ingredients in the amounts as prescribed by the CODEX and, if needed, as prescribed by additional regulations of individual countries.
  • An example of an ingredient list of an infant formula meeting the requirements of the EU, China and Codex can for example be found on www.frieslandcampinaingredients.com/ at app/uploads/2019/04/PDS_ELN_Essential®-Start- IF-110.pdf.
  • the person i.e. human subject as referred to in the various aspect of the invention, is an infant (a person of 0-12 months of age) and the composition is an infant the nutritional composition according to the invention for infants comprises the lipid as described above, protein, carbohydrates, vitamins, minerals and trace elements and the other substances in accordance with the specifications prescribed by the CODEX and, if needed, by additional national regulations.
  • the person i.e. human subject as referred to in the various aspect of the invention, is a young child (a person of 12-36 months of age, - also referred to as toddler) and the composition is a‘follow-up formula for young children' (FUF-YC) - such a formula may also be referred to as‘growing up milks',‘growing up formulas' or‘toddlers' milk', or alternatively it may be referred to as“young child formula”.
  • Such a formula comprises the lipid, protein, and digestible carbohydrates as described above, and may further comprise vitamins, minerals and trace elements and the other substances in accordance with the specifications prescribed by the CODEX STANDARD FOR FOLLOW-UP FORMULA
  • composition as used in the various aspects of the invention is selected from one or more of the group consisting of an infant formula, a follow-up formula and young child formula, preferably, the composition is an infant formula or a follow-up formula, more preferably an infant formula.
  • HMOs Human milk oligosaccharides
  • the composition as used in the aspects of the invention comprises one or more HMOs.
  • the HMOs of human milk are composed of various monosaccharides, namely glucose, galactose, fucose, N-acetylglucosamine and sialic acids (N-acetylneuraminic acid).
  • the sugar fucose is an unusual molecule in that it has the L-configuration, whereas the other sugar molecules in the body have the D-configuration.
  • the structure of HMOs is a lactose unit which may be elongated with one or more galactose and / or N-acetylglucosamine residues (core structure).
  • the HMO core structure may be decorated with one or more fucose residues (i.e. fucosylated HMO) and with one or more sialic acid units (i.e.
  • sialylated HMO may also be fucosylated and sialylated.
  • the HMO in the composition of the invention is selected from one or more the group consisting of core HMO, sialylated HMO, and fucosylated HMO.
  • Nearly 200 HMOs have been identified from human milk. Fucosylated HMOs were found to be the most prominent component (-77%), while sialylated HMOs accounted for about 16% of the total abundance of HMOs.
  • the fucosylated HMOs are neutral molecules, while the sialylated HMOs are acidic.
  • HMO 2'-fucosyllactose
  • a neutral trisaccharide composed of L-fucose, D- galactose, and D-glucose units, linked Fuc(a1-2)Gal ⁇ 1-4)Glc; CAS Nr 41263-94-9
  • concentration about 2 g/l (Adams et at; 2018, Nutrafoods pp 169 - 173).
  • HMOs are 3'-Sialyllactose (3'SL); 6'-Sialyllactose (6'SL); 2'- Fucosyllactose (2'FL); 3-Fucosyllactose (3-FL); lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT) and disialyllacto-N-tetraose (DSLNT); these are preferred HMOs.
  • Particularly preferred nutritional compositions include at least 2'FL.
  • HMOs can be obtained using methods known to those of skill in the art. For example, HMOs can be purified from human milk.
  • HMOs can be further separated using methods known in the art such as capillary electrophoresis, HPLC (e.g., high- performance anion-exchange chromatography with pulsed amperometric detection; HPAEC- PAD), and thin layer chromatography. See, e.g., U.S. Patent Application No. 2009/0098240. Alternately, enzymatic methods can be used to synthesize HMOs. Another method to manufacture HMO’s is via biosynthesis in engineered bacteria. For example, a method of preparing 2’-FL is disclosed in WO 2012/112777. Alternatively, 2’-FL is commercially available e.g. from FrieslandCampina, or others.
  • the composition comprises 0.25 to 20 wt.% non-digestible oligosaccharides based on dry weight of the composition, preferably wherein the non-digestible oligosaccharides are selected from one or more of galacto-oligosaccharides, and fructo-oligosaccharides, more preferably, wherein the non-digestible oligosaccharides are galacto-oligosaccharides.
  • the minimum amount of non-digestible oligosaccharides is at least 1 wt% based on dry weight of the composition, such as at least 5 wt%.
  • the maximum amount of non-digestible oligosaccharide is 25 wt% based on dry weight of the composition, preferably less than 20 wt%, more preferably less than 15 wt%.
  • the person (human subject) preferably is aged 0 to 36 months, 0 to 6 months, 6 to 12 months, 6 to 36 months, 12 to 36 months, 12 to 24 months, 2 to 5 years, 5 to 10 years, 10 to 14 years, 14 to 18 years or 18 years and above. More preferably the human subject is aged 0 to 36 months such as 0 to 12 months or 12 to 36 months. Alternatively, the person is aged 18 years and above.
  • the person i.e. human subject
  • a healthy body weight i.e. a body mass index (BMI) of between 18.5 and below 25.0.
  • BMI is defined as a person’s weight in kilograms divided by the square of the person’s height in meters (kg/m 2 ).
  • the person has an overweight (BMI between 25 and 30) or is obese (BMI > 30).
  • the person has a healthy body weight. It is understood that for persons younger than 18 year old, a healthy body weight is defined as a BMI at or above the 5 th percentile and below the 85 th percentile, overweight is defined as a BMI at or above the 85 th percentile and below the 95 th percentile for children and teens of the same age and sex.
  • Obesity is defined as a BMI at or above the 95 th percentile for children and teens of the same age and sex.
  • VAS Visual Analogue Score
  • VAS visual analogue score
  • human milk fat consists of triacylglycerols (TAG) that contain saturated and unsaturated fatty acids esterified at the sn-1 , sn-2 and sn-3 position of a glycerol molecule.
  • TAG triacylglycerols
  • human milk fat, bovine milk fat and vegetable oils such as palm oil are all rich in palmitic acid (C16:0)
  • palmitic acid C16:0
  • the distribution of palmitic acid over the glycerol backbone differs among these different lipid sources.
  • palmitic acid In human milk fat most of the palmitic acid is esterified at the sn-2 position of the glycerol molecule.
  • the lipid comprises at least 10 wt% palmitic acid based on total fatty acids, such as at least 15 wt%, 20 wt% or even at least 25 wt%, and at least 15 wt% of palmitic acid, based on total palmitic acid, is located at the sn-2 position of a glycerol molecule (glyceride).
  • glycerol molecule glyceride
  • the lipid comprises at least 20 wt% palmitic acid based on total fatty acids and at least 20 wt% of palmitic acid or even at least 25 wt% or even at least 30 wt%, based on total palmitic acid, is located at the sn-2 position of a glycerol molecule.
  • the amount of palmitic acid is 15 to 30 wt.% based on total fatty acids and 25 to 40 wt.% of the palmitic acid is in the sn-2 position in a triglyceride.
  • SCFA milk fat from ruminant animals
  • SCFA are known to be easily absorbed and transported to the liver for fast oxidation.
  • Bovine milk fat contains from 7.5 to 13.0 mol butyric acid/100 mol FA. Because
  • dibutyrylacylglycerols are present in trace amounts only, this means that about one third of milk fat triacylglycerols contain one molecule of butyrate. Accordingly, in another
  • At least 10% of the lipid molecules i.e.
  • triacylglycerols comprise one molecule of butyrate, preferably at least 15%, more preferably at least 20%, even more preferably at least 25% of the lipid molecules (i.e. triacylglycerols) comprise one molecule of butyrate.
  • Docosahexaenoic acid (DHA) is an omega-3 fatty acid that is a primary structural component of the human brain, cerebral cortex, skin, and retina. In physiological literature, it is given the name 22:6(n-3). It can be synthesized from alpha-linolenic acid or obtained directly from maternal milk (breast milk), fish oil, or algae oil. DHA is believed to support brain function and eye health.
  • the lipid comprises at least 0.1 wt.% docosahexaenoic acid based on total fatty acids, preferably at least 0.2 wt%, more preferably at least 0.4 wt%.
  • Glycerophospholipids and sphingolipids are quantitatively the most important phospholipids (PLs) in milk. They are located on the milk fat globule membrane (MFGM) and in other membranous material of the skim milk phase. They include principally
  • the lipid comprises at least 5 wt.% sphingomyelin based on total phospholipids, preferably at least 7 wt%, more preferably at least 10 wt%.
  • the lipid globules comprise a coating comprising phospholipid.
  • the amount of protein in the composition used in the method of the invention preferably is between 1.8 g to 3.5 g protein/100 kcal in order to meet dietary requirements, preferably between 1.8 g to 2.1 g protein/100 kcal; more preferably, the composition comprises between 1.8 and 2.1 g protein / 100 kcal and 4 to 6 g lipid/100 kcal; and 5 to 20 g digestible carbohydrates/100 kcal.
  • the amount of energy in the composition used in the method of the invention preferably is between 60 to 70 kcal per 100ml, when the
  • composition is ready to drink.
  • the composition used in methods of the invention may be ready to drink, or may be a dry powder.
  • the composition usually is combined with instructions on how to convert the powder in a drinkable formula e.g. by specifying the amount of powder to be dissolved in 100 mL of water.
  • the method of the invention for inducing satiety in a human can be combined with a meal replacement, a weight reduction program or a weight maintenance program.
  • the invention also provides a kit for inducing satiety or suppressing appetite comprising a meal replacement product and a composition as defined for the method of the invention.
  • the composition as described herein above e.g. in various aspects of the method of the invention may in other aspects be used in a weight reduction or weight maintenance program comprising administering a person a composition as defined elsewhere herein; or alternatively in a non-medical method for inducing satiety in a person comprising
  • the invention in another aspect relates to a composition
  • a composition comprising lipid, protein and digestible carbohydrates; wherein the lipid comprises i. 30 to 90 wt.% vegetable fat, and ii. 10 to 70 wt.% mammalian milk fat, wherein all wt.% are based on total lipid of the composition, characterized in that the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90% for use in inducing satiety in a person.
  • the invention relates to the use of lipid, protein and digestible carbohydrates; wherein the lipid comprises i. 30 to 90 wt.% vegetable fat, and ii. 10 to 70 wt.% mammalian milk fat; wherein all wt.% are based on total lipid of the composition, characterized in that the lipid is present in the form of lipid globules with the volume % of lipid globules with a diameter below 2 pm is above 60%, preferably above 70%, more preferably above 80, most preferably above 90% in the manufacture of a composition for inducing satiety in a person.
  • Some people may have an allergic reaction or sensitivity to
  • the composition as used in the invention is free of carboxymethylcellulose, propylene glycol alginate and / or soy fibre.
  • the level of restraint eating was determined with the Dutch eating behavior questionnaire (van Strien et al 1986, The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. Int J Eat Disord. John Wiley & Sons, Ltd; 1986;5:295-315), subjects with a score 3 30 were excluded.
  • DEBQ Dutch Eating Behavior Questionnaire
  • the study was a double-blind randomized crossover trial involving two days of testing separated by at least one week. On the day preceding a study day, participants were restricted from exercise, alcohol consumption and use of drugs. A standardized dinner containing 584 kcal, 15.0 g fat, 63.9 g carbohydrates, and 43.3 g protein, was provided to the subjects After overnight fasting of 12 hours, subjects were transported by car to the research location. A catheter was placed in the forearm, and participants were asked to lay down on a bed for at least 30 minutes to ensure a resting state. Thereafter, indirect calorimetry was performed using a ventilated hood system (MAX-II Metabolic System, AEI technologies Inc, USA), for determinations of basal energy metabolism.
  • MAX-II Metabolic System AEI technologies Inc, USA
  • VAS visual analogue scale
  • Infant Formula (IF) base powders provided by FrieslandCampina, were used to produce the test drinks.
  • the products were isoenergetic and equal in nutrient composition, see Table 2.
  • the test drinks only differed in fatty acids profile (Table 3).
  • One test drink contained a mixture of vegetable fats only (VEG), the other contained 67% bovine milk fat and 33% of vegetable fats (BOV).
  • the powdered product was diluted in lukewarm water, with a ratio of 1 :2.1. To correct for difference in energy expenditure of the participants the total amount of study product to be consumed by participants was based on their total energy expenditure, which was calculated by multiplying the basal metabolic rate with the physical activity level. (TEE).
  • Basal metabolic rate was calculated using the Harris-Benedict equation), based on age, height, and weight. (Harris JA, Benedict FG, 1918 A biometric Study of Human Basal Metabolism. Proc Natl Acad Sci USA, 1918;4(12):370-373) A physical activity level of 1.75 was used to determine the TEE. The participants received a test drink of which the energy represented 30% of their calculated TEE. Randomization of the treatment was performed with a random sequence generator.
  • composition per 100 gram
  • VEG contains a mixture of vegetable fats only
  • BOV contains 67% bovine milk fat and 33% of vegetable fats Table 3. Fatty acid composition of the two test drinks (in weight% of total FAMEs).
  • VEG contains a mixture of vegetable fats only
  • BOV contains 67% bovine milk fat and 33% of vegetable fats
  • Lipid globule particle size analysis was performed by laser diffraction using a Malvern Hydro LV Mastersizer 3000. Analysis were performed with an obscuration of 10 ⁇ 2. Refractive indexes of 1.33 (water) and 1.47 (vegetable oil) were chosen for the continuous and dispersed phases, respectively. The absorbance was 0.001 and the Mie-model was used for converting the scattering data to size distributions and characteristic diameters. The system was calibrated using polydisperse glass-bead transfer standard. Fatty acid determination
  • the content of the different fatty acids in the lipid of the composition of the invention can be determined by standard method ISO 15884/IDF 182:2002 (Milk fat - Preparation of fatty acid methyl esters) and ISO 15885/IDF 184 (Milk fat - Determination of the fatty acid composition by gas-liquid chromatography). These ISO methods allow for determination of molar concentration of a fatty acid relative to total moles of this fatty acid in TAG ([FA-TAG]). The distribution of fatty acids over the glycerol backbone can be determined according to the method disclosed in Luddy.F.E., Barford.R.A., Herb.S.F., Magidman.P. and
  • this method involves hydrolysis of triacylglycerols (TAG) by a sn-1 ,3 specific pancreatic lipase (porcine).
  • TAG triacylglycerols
  • porcine pancreatic lipase
  • the required 2-monoacylglycerols formed are isolated by thin layer chromatography and these are subsequently methylated for gas chromatographic analysis and quantified in molar concentrations relative to the total moles of fatty acids at the sn-2 position ([FA(sn-2)]).
  • the milk fat source can in principle be any available bovine milk fat source, such as whole milk, cream, anhydrous milk fat (AMF) or milk fat fractions resulting from dry fractionation, critical CO2 extraction or other fractionation methods known in the art. It was, however, found particularly suitable to use whole milk and/or cream as the milk fat source.
  • AMF anhydrous milk fat
  • the indirect calorimetry system MAX-II Metabolic System (AEI technologies Inc, USA) was used to determine 02 consumption and C02 production. Energy expenditure was calculated using the equations of Weir (20). The basal energy expenditure was determined in fasted state, after 30 minutes of rest. By subtracting this basal energy expenditure from the energy expenditure that was measured after consumption of the drinks the diet-induced
  • thermogenesis (DIT) could be calculated.
  • VAS visual analogue scale
  • VAS is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line (10cm) between two end-points. The end points used were“not at all” and“extremely”. VAS was used since the subjective measurement represents in a robust and reproducible way the condition of the subject in this respect (Raben et al, 1995 Determinants of postprandial appetite sensations: macronutrient intake and glucose metabolism. Int J Obes 1995, 20, 161-169).
  • Averages of DIT were calculated per 30 minutes. Net area under the curve (netAUC) was calculated for DIT, and compared with a Wilcoxon matched-pairs signed rank test. To be able to compare the two products, the VAS scores were corrected for baseline values, and the scores from 30-300 minutes were analyzed with linear regression. Glucose and gastrointestinal peptides were corrected for baseline values, netAUC was calculated, and the two products were compared by a Wilcoxon matched-pairs signed rank test. Spearman correlation analyses were performed for DIT and VAS scores, gastrointestinal peptides and VAS scores, and gastrointestinal peptides and DIT.
  • Protein content was determined in accordance with ISO-8968-2, using a multiplication factor of 6.25.
  • the mode diameter of the test products (VEG and BOV) were 0.36 ⁇ 0.05 pm and 0.46 ⁇ 0.05 pm, respectively.
  • the volume percentages of lipid globules with a diameter below 1 pm was 80% and the volume % of lipid globules with a diameter below 2 pm was 92%.
  • a method comprising feeding an infant an infant formula or follow on formula comprising lipid, protein and digestible carbohydrates, and wherein the lipid comprises i) 30 to 90 wt.% vegetable lipid based on total lipid, and ii) 10 to 70 wt.% based on total lipid of mammalian milk lipid derived wherein the lipid is in the form of lipid globules, which had a mode diameter, based on volume, of about 5.6 pm, and the volume % of lipid globules with a diameter between 2 and 12 pm was above 45%; a similar composition comprising lipid, protein and digestible carbohydrates wherein the lipid is present in the form of lipid globules with the volume % of lipid globules with a mode diameter of 0.46 pm, and the volume% of lipid globules with a diameter below 2 pm is above 60% has an effect of inducing

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